FDA UDI
In Commercial Distribution
🇺🇸 United States
Pure-Vu EVS System
DI: 05060513700151
·
Model: PV-WSC-03-0
·
MOTUS GI MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pure-Vu EVS System
- Primary DI
- 05060513700151
- Version / Model
- PV-WSC-03-0
- Catalog Number
- PV-WSC-03-0
- Company Name
- MOTUS GI MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 532775983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-06
- Public Version
- 1
- Public Version Date
- 2023-09-14
- Public Version Status
- New
- Public Device Record Key
- 23f63669-09d6-4a85-b983-86c9972e7540
Device Description
(1) EVS Workstation with foot pedal
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12301 | Colonic lavage system, powered-flow | A device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris from the colon. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated fluids (e.g., saline), an extractor (frequently using vacuum), and controls for the temperature and the rate of infusion (e.g., using a nozzle) and withdrawal of the liquid; the system is coupled to dedicated handpieces and/or to disposable catheters introduced through the rectum. It is intended to be used by a healthcare provider in a clinical setting to remove damaged tissue and/or debris (e.g., faeces, foreign objects). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060513700151 | GS1 |
Customer Contacts
- Phone
- 888-438-9996
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220007 | 000 |